Registration of Import License for IVD’S In India.

Authors

  • Inamdar Yashashri M Shri D.D. Vispute College of Pharmacy & Research Center, New Panvel.

DOI:

https://doi.org/10.22270/ajprd.v11i4.1297

Keywords:

Medical Device, Registration, Import License, Regulation​

Abstract

India is a huge market for medical devices and is constantly increasing last few years. The registration certificate and import license is mandatory for manufacturer of India who wishes to import any medical device in India. Indian Agent authorized by CDSCO is required for registering the medical device in India. Duly filled Form MD-14 is required to be submitted for import license registration and license obtained will be in Form MD-15. The review focuses on the regulations concerned to the registration procedures import for new medical device in India with latest amendments in the regulation concerned.

 

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Author Biography

Inamdar Yashashri M, Shri D.D. Vispute College of Pharmacy & Research Center, New Panvel.

Shri D.D. Vispute College of Pharmacy & Research Center, New Panvel.

References

1. Manu M and An and G. A review of medical device regulations in India, comparison with European Union and way-ahead. National Library of Medicine.2021; 13(1).
2. Saminathan J* and Patel R. Current Regulatory Challenges and Approaches in Registering In-Vitro Diagnostics (IVD???s) in India. Journal of Basic and Clinical Pharmacy. 2017; 8.
3. https://cdsco.gov.in › sites › IVD › FAQs › CD In-Vitro Diagnostic (IVD) Medical Devices CDSCO
4. https://morulaa.com/registration-services-in-india-cdsco/
5. Budhwar V, Rohilla Y, Manjusha C, Kumar P.Regulations Of Registration And Import Of Medical Device In India.International Journal of Drug Regulatory Affairs. 2018; 6(1).

Published

2023-08-13

How to Cite

Yashashri M, I. (2023). Registration of Import License for IVD’S In India. Asian Journal of Pharmaceutical Research and Development, 11(4), 123–125. https://doi.org/10.22270/ajprd.v11i4.1297

Issue

Vol. 11 No. 4 (2023): Vol 11 No 4 (2023): Volume 11 Issue 4 July - August. 2023

Section

Review Articles

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